Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP

Adult Idiopathic Generalized Osteoporosis Clinical Trial

Official title:

Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With Idiopathic Osteoporosis (IOP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02049866
• Other study ID #: AAAN0161
• Secondary ID: 1R01FD005114-01A
• Status: Completed
• Phase: Phase 2
• Start date: November 19, 2014
• Est. completion date: December 23, 2021

Study information

• Verified date: October 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to evaluate antiresorptive therapy with denosumab (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal women with idiopathic osteoporosis.

Premenopausal women who have received TPTD in the FDA Orphan Diseases Program-funded trial, "A Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women" (NCT01440803) may be eligible to participate in the current study, a 36-month open-label pilot study of denosumab (Prolia®, 60mg subcutaneous (SC) every 6 months).

The goals of the study are to estimate the effects of denosumab on central and peripheral, as well as trabecular and cortical, bone mass and microstructure and to obtain preliminary data to inform the design of a future randomized study. This study presents the first opportunity to study the effects of denosumab after TPTD in this unique and severely affected group of young women.

Funding Source: FDA Office of Orphan Products Development (OOPD).

Description:

Osteoporosis in premenopausal women with normal menstrual function and no specific cause is termed idiopathic osteoporosis (IOP). IOP is a rare disease with an estimated prevalence of <200,000 affected premenopausal women in the United States.

Denosumab, a potent inhibitor of osteoclast-mediated bone resorption, leads to continuous gains in both trabecular and cortical bone mineral density (BMD). Moreover, denosumab is not retained in the skeleton, and may thus be preferable for use in young women who may be contemplating future pregnancies. The investigators hypothesize that denosumab, initiated after completion of two years of TPTD, will maintain or improve central and peripheral areal and volumetric BMD, microstructure and stiffness in premenopausal women with IOP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 23, 2021
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• All women completing NCT01440803 who remain without a disease or medication that causes osteoporosis will be offered enrollment into this study.

• (Premenopausal status is no longer be required for entry.)

Exclusion Criteria:

• Renal insufficiency or liver disease: Creatinine, transaminase (AST)/alanine transaminase (ALT) above upper limit of normal

• Vitamin D deficiency: 25-hydroxyvitamin D (25-OHD) <30 ng/mL

• Pregnancy: urine pregnancy test must be negative

Related Conditions & MeSH terms

• Adult Idiopathic Generalized Osteoporosis
• Osteoporosis

Intervention

Drug:
• Denosumab
Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York
United States	Creighton University	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Elizabeth Shane	Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Lumbar Spine Areal BMD by DXA	Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).	Baseline and 12 months
Secondary	Percent Change in Lumbar Spine Areal BMD by DXA at 24 Months	Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).	Baseline and 24 months

External Links

•   Columbia University, Dept of Medicine, Division of Endocrinology website